Registry of Major Liver Resections Including ALPPS and Other Liver Resections in Two Stages

• Conditions: Liver Neoplasms; Liver Regeneration

• Registration Number: NCT01924741
• Lead Sponsor: University of Zurich

Brief Summary

Recently a new method of induce similar hypertrophy in the liver as is observed after hepatectomy has been described and was given the eponym "ALLPS". "ALPPS" stands for Associating Liver Partition with Portal Vein Ligation for Staged Hepatectomy (ALPPS).

Since the procedure is used worldwide this international registry was created to enable tracking of cases performed worldwide for safety and outcomes and innovations by the groups involved as well as allows a non-randomized comparison to the conventional methods of portal vein occlusion.

Detailed Description

The ALPPS registry is accessible online through the data portal www.allps.net. Registered members recieve access through a member ID and password. Data submission is supported by the SECUTRIAL software, supported by the Clinical Trials center of the University of Zurich.

All data submitted are anonymized before entry through the SECUTRIAL Software. Administration of the registry data is performed through the Department of Visceral and Transplantation Surgery in the University Hospital Zurich and the Clinical Trials Center of the University of Zurich, Switzerland, in collaboration with the Italian Hospital in Buenoas Aires, Argentina.

A Scientific Committee has been appointed to give approval for any data analysis. Any participating center may apply for data analysis.

Particiating International Centers have responsibility for the validity of the data submitted and the respective local institutional review procedures.

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-14
• Study First Submitted QC: 2013-08-14
• Study First Posted: 2013-08-16
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-30
• Last Update Posted: 2014-07-31
• Primary Completion: 2015-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• All Patients who undergo the new ALPPS procedure
• Patients undergoing any other modification of ALPPS like portal vein embolization (PVE) or banding of the liver with portal vein ligation or embolisation or other liver resection in two stages resembling ALPPS_
• Male and Female patients 18 years to no limit
• Prior registering the data, patient was informed and did not object to the use of his/her anonymized medical data in this registry

Exclusion Criteria

• No exclusion criteria apply for a registry

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Morbidity and mortality (peripoerative)	3 months	Primary outcome variablesis perioperative mortality and complications and survival status after 3 months. Data will be entered following the widely accepted Clavien-Dindo classification system .

Secondary Outcome Measures

Name	Time	Method
Long term survival	5 years	Outcome variables include long term survival after 3, 6, 12, 18 and 24 month, survival status after 3, 4, and 5 years. If the patient is still alive the data about hepatic recurrence and systemic recurrence will be collected. If there is a recurrence the type of treatment will be recorded.
Perioperative liver and renal function	5 days	Outcome variables include liver and renal function after surgery. INR and Total bilirubin as well as creatinine prior to surgery and 5 days after stage 1 and five days after stage 2 are recorded and commonly accepted citeria for postoperative liver and postoperative renal failure are used to assess these 2 types of complications.
Disease specific recurrence/failure to cure	5 years	Outcome variables include disease specific failure to cure (to completely resect) or disease specific recurrence after 3, 6, 12, 18 and 24 month, survival status after 3, 4, and 5 years. If there is a failure to cure or recurrence, the type of treatment will be recorded.
Liver Growth as assessed by imaging-based volumetry	between stage 1 and stage 2 (1-12 weeks)	Outcomes variables include Liver Growth as assessed by imaging-based volumetry between stage 1 and stage 2 (1-12 weeks)as assessed either by computer tomography or magnetic resonance based volumetry

Trial Locations

Locations (1)

University Hospital Zurich; 🇨🇭 Zurich, Switzerland